Budget Impact of Aripiprazole 2-Month Ready to Use Long-Acting Injectable for Adult Patients with Bipolar I Disorder in the United States

Abstract: Background Aripiprazole 2-Month Ready to Use (ARI 2M RTU) formulation is a long-acting injectable (LAI) currently in development as a treatment for schizophrenia and maintenance monotherapy for bipolar I disorder (BP-I) in adults . This budget impact (BI) model examines the financial impact of introducing ARI 2M RTU into the existing treatment mix as maintenance monotherapy for adult patients with BP-I. Methods The BI model includes a hypothetical health plan cohort of 1,000,000 adult patients (≥ 18 years old) with BP-I (defined by DSM-5 criteria) eligible for maintenance monotherapy (2.3%; Nf23,000). Wholesale acquisition cost (WAC) for currently prescribed treatments, expected WAC for ARI 2M RTU, and administration costs for each treatment over a 3-year period (base case) and changes in market shares were used to estimate the BI of the launch of ARI 2M RTU (new versus current treatment mix). Results The total budget impact of ARI 2M RTU for BP-I is $ 5,334,331 over 3 years. The Per Member Per Month cost is $0.45 while the Per Treated Member Per Month cost is $39.44. Sensitivity analyses support the findings with respect to the BI, with and without ARI 2M RTU. Conclusions The introduction of ARI 2M RTU as a maintenance treatment for adult patients with BP-I is expected to have a minimal impact on payer budgets in the US.Short Description: The purpose of this budget impact analysis was to examine payer's financial consequences from Aripiprazole 2-Month Ready to Use (ARI 2M RTU) Long-Acting Injectable for Adult Patients with Bipolar I (BP-I) Disorder entering the market in the United States (US). Our results suggest that the introduction of ARI 2M RTU as a maintenance treatment for adult patients with BP-I is expected to have a minimal impact on payer budgets in the US.Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc.